Condition category
Infections and Infestations
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
30/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://jc.med.uu.nl/sdd

Contact information

Type

Scientific

Primary contact

Dr Anne Marie G A de Smet

ORCID ID

Contact details

University Medical Center Utrecht
AZU
PO Box 85500
Amsterdam
3508 GA
Netherlands
+31 (0)30 2509111
a.desmet@azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SDD-SOD-trial

Study hypothesis

Can mortality in intensive care unit (ICU) patients be reduced by using SDD or SOD as infection prevention measure, without increasing the development of antibiotic resistance?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Infection in ICU patients

Intervention

Selective Digestive Decontamination.
Selective Oropharyngeal Decontamination.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Hospital mortality
2. ICU-mortality

Secondary outcome measures

1. Prevalence of antibiotic resistance
2. Duration of mechanical ventilation,
3. Duration of ICU-stay,
4. Incidence of hospital infections,
5. Antibiotic use,
6. Health care costs.

Overall trial start date

01/05/2004

Overall trial end date

24/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All patients admitted to the ICU with an expected stay> 72 hours in ICU or with an expected duration of mechanical ventilation > 48 hours

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

3,450

Participant exclusion criteria

1. Known allergy to study-medication in patient-history
2. Pregnancy

Recruitment start date

01/05/2004

Recruitment end date

24/07/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht, AZU
Amsterdam
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (Netherlands)

Sponsor details

PO Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Other

Funder name

Dutch SDD Trialists Group (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19118302
2. 2010 survery results in http://www.ncbi.nlm.nih.gov/pubmed/20626848
3. 2911 results in http://www.ncbi.nlm.nih.gov/pubmed/21420908

Publication citations

  1. Survery results

    Jongerden IP, de Smet AM, Kluytmans JA, te Velde LF, Dennesen PJ, Wesselink RM, Bouw MP, Spanjersberg R, Bogaers-Hofman D, van der Meer NJ, de Vries JW, Kaasjager K, van Iterson M, Kluge GH, van der Werf TS, Harinck HI, Bindels AJ, Pickkers P, Bonten MJ, Physicians' and nurses' opinions on selective decontamination of the digestive tract and selective oropharyngeal decontamination: a survey., Crit Care, 2010, 14, 4, R132, doi: 10.1186/cc9180.

  2. Results

    de Smet AM, Kluytmans JA, Blok HE, Mascini EM, Benus RF, Bernards AT, Kuijper EJ, Leverstein-van Hall MA, Jansz AR, de Jongh BM, van Asselt GJ, Frenay IH, Thijsen SF, Conijn SN, Kaan JA, Arends JP, Sturm PD, Bootsma MC, Bonten MJ, Selective digestive tract decontamination and selective oropharyngeal decontamination and antibiotic resistance in patients in intensive-care units: an open-label, clustered group-randomised, crossover study., Lancet Infect Dis, 2011, 11, 5, 372-380, doi: 10.1016/S1473-3099(11)70035-4.

  3. de Smet AM, Kluytmans JA, Cooper BS, Mascini EM, Benus RF, van der Werf TS, van der Hoeven JG, Pickkers P, Bogaers-Hofman D, van der Meer NJ, Bernards AT, Kuijper EJ, Joore JC, Leverstein-van Hall MA, Bindels AJ, Jansz AR, Wesselink RM, de Jongh BM, Dennesen PJ, van Asselt GJ, te Velde LF, Frenay IH, Kaasjager K, Bosch FH, van Iterson M, Thijsen SF, Kluge GH, Pauw W, de Vries JW, Kaan JA, Arends JP, Aarts LP, Sturm PD, Harinck HI, Voss A, Uijtendaal EV, Blok HE, Thieme Groen ES, Pouw ME, Kalkman CJ, Bonten MJ, Decontamination of the digestive tract and oropharynx in ICU patients., N. Engl. J. Med., 2009, 360, 1, 20-31, doi: 10.1056/NEJMoa0800394.

Additional files

Editorial Notes